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To compare the efficiency of drops versus the specially designed spectacles (DIMS) to slow down the increase in myopia (shortsightedness) in children.

Efficacy of DIMS spectacle lenses among non-responders to 0.01% low dose Atropine.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050441
Enrollment
186
Registered
2023-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H521- Myopia

Interventions

Intervention1: Myopia control treatment lenses (DIMS) and 0.01% Atropine drops.: Comparison of strategies for slowing down the myopia progression among the children who respond poorly to low dose Atro

Sponsors

HOYA Holdings
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Children with myopia of SE between -0.50 D and -10.00 D (combination of -6.00DS and -4.00 DC) of age group 6-12 years 2) Documented history of myopia progression by more than - 0.50D and/or increase in axial length by more than 0.20mm between 6 months to one year while using 0.01% atropine once daily 3) Corrected VA is = 0.1 Log MAR or 0.8 in Snellen.

Exclusion criteria

Exclusion criteria: 1) Prior use of 0.01% low dose atropine twice a day 2) History of any previous myopia control intervention other than 0.01% low dose atropine 3) History of any ocular or systemic disease 4) History of any previous ocular surgery or trauma 5) Anisometropia > - 2.00 D; Astigmatism > - 1.50 D and Amblyopia 6) Any hypersensitivity/allergic reaction with use of 0.01% atropine 7) Myopia of higher than -8.00D (limited by availability of DIMS spectacle lens in power higher than that)

Design outcomes

Primary

MeasureTime frame
Rate of myopia progression in terms spherical equivalent over 1 year of period.Timepoint: At baseline, 6 months and 1 year (total 18 months)

Secondary

MeasureTime frame
To evaluate the change in axial length and choroidal thickness over 18 months.Timepoint: At baseline, 6 months and 1 year (total 18 months)

Countries

India

Contacts

Public ContactSumita Agarkar

Medical Research Foundation, Sankara Nethralaya

drsar@snmail.org9840462369

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026